Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)

Inclusion criteria

• Aged 18 years or older;
• Male or non-pregnant female patients; women of childbearing potential must undergo a pregnancy test prior to enrollment, and the result must be negative;
• Willing and able to provide written informed consent;
• Maximum diameter of the abdominal aortic aneurysm (AAA) ≥ 4.5 cm in females or ≥ 5 cm in males;
• Proximal neck diameter of the AAA ranging from 19 to 32 mm;
• Distal fixation zone length of both iliac arteries ≥ 15 mm;
• Diameter of iliac artery fixation zones on both sides ranging from 8 to 25 mm;
• ≤ 60° infrarenal and ≤ 45°suprarenal angulation OR ≤ 75°infrarenal and ≤ 60°suprarenal angulation with proximal necks ≥ 15 mm in length;
• Presence of high-risk anatomical criteria, defined as meeting any one of the following criteria:

• Proximal neck diameter > 28 mm and ≤ 32mm
• Proximal neck length ≥ 10 mm and < 15 mm
• Neck angulation ≥ 60°and ≤ 75° (angle between the long axis of the proximal neck and the long axis of the aneurysm sac)
• Conical neck (defined as diameter increased > 10% compared with the immediate infrarenal diameter over the first 10 mm beyond the lowest main renal artery)
• Investigator determined subject could benefit from this Heli-FX procedure
• Patients deemed by the investigator to be suitable candidates for elective AAA repair;
• Patients who agree to return to the treating investigator for all scheduled follow-up visits and are able to attend hospital-based follow-up;
• Life expectancy > 2 years

Exclusion criteria

• Myocardial infarction within the past 3 months;
• Systemic infection;
• Ruptured or leaking AAA;
• Infected or inflammatory AAA;
• Known hereditary connective tissue disorders (e.g., Marfan syndrome or Ehlers-Danlos syndrome);
• Concomitant thoracic aortic aneurysm or thoracoabdominal aortic aneurysm;
• Requirement for emergency AAA repair;
• History of prior AAA repair;
• Patient body habitus that interferes with required imaging studies;
• In the opinion of the investigator, the patient has serious comorbidities that may pose an unacceptable risk for general anesthesia or endovascular intervention;
• Planned major surgery (e.g., thoracic aorta, renal, superior mesenteric artery/celiac or lower extremity revascularization, IMA reimplantation, permanent vascular access, cholecystectomy) concurrent with or within 30 days before or after the AAA repair procedure;
• Renal failure requiring dialysis;
• Patient has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment;
• Known hypersensitivity or allergy to polyester, nickel, titanium, tantalum, chromium, molybdenum, and/or cobalt;
• Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure;
• Bleeding diathesis or hypercoagulable state;
• Sealing zone thrombus, calcium or plaque > 2 mm in thickness or covering > 50% (180 degrees) of the vessel circumference;
• Irregularly shaped calcification and/or plaques at the proximal implantation sites that may interfere with proper deployment of the EndoAnchor implants;
• Mental disorders or other conditions that may impair the patient's ability to understand the nature, significance, and/or scope of the study;
• Participation in another investigational drug or device trial without having completed the required follow-up.
• Endograft planned to be used had not undergone in vitro evaluation to confirm its compatibility with the EndoAnchor implant and the aortic fixation system.